Dear Mr Murray, Re: Regulation 28 Report to Prevent Future Deaths – Neil John Clarke who died on 26 February 2024.

Thank you for your Report to Prevent Future Deaths (hereafter “Report”) dated 2 July 2025 concerning the death of Neil John Clarke on 26 February 2024. In advance of responding to the specific concerns raised in your Report, I would like to express my deep condolences to Neil’s family and loved ones. NHS England is keen to assure the family and yourself that the concerns raised about Neil’s care have been listened to and reflected upon.

The first concern raised in your Report was over the considerations given to the appropriateness, from a safety and wellbeing perspective, of surgical procedures involving elderly patients who may benefit from conservative measures, together with the associated documentation and guidance advising patients of different treatment choices.

Clinicians’ decisions regarding appropriate care require weighing up the risks and benefits of a procedure, combined with the patient’s own views, to achieve effective shared decision making.

Neil is described as a ‘fit 81 year old’. The Office of National Statistics (ONS) data demonstrates that an 81 year old man has, on average, a life expectancy of 8 years ahead of them, until aged 89, and so it would seem appropriate that a fit 81 year old man would have been considered for both surgical interventions and conservative measures. However, life expectancy is also influenced by frailty and medical history. The most widely used tool for quantification of frailty in the NHS is the Rockwood Clinical Frailty Scale (CFS): National Medical Director NHS England Wellington House 133-155 Waterloo Road London SE1 8UG

20 August 2025

An 81 year old man with a CFS of 7 entering a nursing home has a life expectancy, on average, of little over a year. Reciprocally, a ‘fit’ 81 year man (CFS 1-2) will have, on average, a life expectancy of 9 years or more.

To be able to achieve effective shared decision making on treatment choices also requires information on the potential risk/benefits of the different surgical options. NHS England notes from your Report that different options were provided and discussed with Neil, to include conservative management, further polypectomy or a right hemicolectomy, the latter being advised as the most appropriate option by clinicians.

There is clear national guidance on perioperative care for both adults and specifically older people from the National Institute for Health and Care Excellence (NICE) and the British Geriatrics Society (BGS) respectively.

• NICE Guidance NG180: Perioperative care in adults (published 19 August 2020) Recommendations | Perioperative care in adults | Guidance | NICE
• BGS Good Practice Guide: Peri-operative Care for Older Patients Undergoing Surgery (published 23 January 2015)

Peri-operative Care for Older Patients Undergoing Surgery | British Geriatrics Society

NHS England has also undertaken considerable work to develop the following guidance on Early screening, triaging, risk assessment and health optimisation in perioperative pathways: guide for providers and integrated care boards (published in May 2023 prior to Neil’s death and updated in May 2025), which includes information on risk assessment and shared decision making. Point 5 under the ‘Five core requirements for providers’ states:

“Patients must be involved in shared decision-making conversations to discuss the benefits, risks, alternatives and likely outcomes of the surgery, as well as the postoperative recovery period. This allows patients to confirm their decision to proceed with the surgery, seek further specialist advice if required or make the informed choice to pursue alternative options”.

Our Personalised Care Team have also produced supporting information on shared decision making including ‘Decision support tools’ resources, also called patient decision aids, to support shared decision making by making treatment, care and support options explicit.

It is outside of NHS England’s remit to provide comment on the appropriateness of the clinical decision to proceed with a right hemicolectomy in Neil’s case. The clinical team at Stepping Hill Hospital would be best placed to comment upon the specific circumstances of this case.

Your second concern focused on the accuracy of handover communications between clinical staff regarding patients returning to the main ward from the High Dependency Unit (HDU) at Stepping Hill Hospital.

Safe and appropriate handover of patients is a basic and core aspect of all clinical care. We refer the Coroner to Stockport NHS Foundation Trust’s response to your Report, on behalf of Stepping Hill Hospital, regarding this concern. NHS England has also asked to be sighted on their response and will consider this carefully.

I would also like to provide further assurances on national the NHS England work taking place around the Reports to Prevent Future Deaths. All reports received are discussed by the Regulation 28 Working Group, comprising Regional Medical Directors, and other clinical and quality colleagues from across the regions. This ensures that key learnings and insights around events, such as the sad death of Neil, are shared across the NHS at both a national and regional level and helps us to pay close attention to any emerging trends that may require further review and action.

Thank you for bringing these important patient safety issues to my attention and please do not hesitate to contact me should you need any further information.

Dear Mr Murray

Re: Death of Neil John Clarke NHS number: Inquest date: 1 May 2025

I am writing to you further regarding the Inquest into the death of Mr Neil Clarke which concluded on 1 May 2025 and the request for assurance in respect of the following:

• Consideration to be given to the appropriateness, from a safety and well-being perspective, of surgical procedures involving elderly patients who may benefit from more conservative measures and the associated documentation and guidance advising patients of different treatment choices.

Medical professionals, particularly those working with older adults, receive training and guidance on ensuring informed consent and discussing all treatment options with their patients. This training is integrated throughout a doctor’s career, from medical school through ongoing professional development. Training is guided by principles and regulations from bodies such as the General Medical Council and the Quality Care Commission. Training has an emphasis on shared decision making, where the doctor acts as an expert in medical options, and the patient is the expert in their own values and preferences, which encourages a collaborative approach.

Training also highlights the importance of providing patients with all relevant information about their condition, prognosis, and available treatment options, including the option to take no action. This information must also cover potential benefits, risks, side effects, and complications associated with each option. Additionally, it is also best practice for the suitability of an elderly patient to undergo surgery to be discussed within a multidisciplinary team meeting, especially for those patients deemed at are at a higher risk. This allows for a more balanced assessment of the benefits and risks of surgery versus alternative treatments or no treatment, leading to a more individualized and patient-centered care plan. This was the case for Mr Clarke following MDT review in September 2023.

Chief Executive Stockport NHS Trust Poplar Grove Stockport Cheshire SK2 7JE

I can confirm that the Trust undertook a review of the Trust’s Consent Policy in 2024 which stipulated a healthcare professional responsible for seeking consent must have received appropriate consent training.

Consent training was not originally a requirement of the Core Skills Training Framework for mandatory or role specific training, however, it is a key component of CQC assessments to ensure that we are delivering safe, effective and person centered care. Consent training provides healthcare professionals with the knowledge and skills to communicate effectively with patients; assess their capacity to give consent; understand and decide when and how to involve family members or legal representatives and how to document appropriately to meet legal and ethical compliance.

A proposal was made for the provision of consent training and to align this as essential training for clinical staff with patient facing roles to be delivered by an appropriately sourced e-learning module and adapted to align with Trust needs. The proposal was approved and Mandatory Consent Competency requirement was rolled out on 22 July 2025. All clinical staff involved in delivering patient care have the requirement attached to their position in ESR (Electronic Staff Record) and will be auto-enrolled in the relevant e-Learning packages. A timeframe of October 2025 has been set for completion by all relevant staff with a three year rolling programme.

Compliance for this training requirement would then be reported through governance processes including the Educational Governance Group, Patient Safety Group and at Divisional meetings.

• Accuracy of hand over communications between clinical staff in respect of

patients returning to the main ward from HDU. , Divisional Nursing Director, together with would like to assure you that changes to process had been implemented prior to Mr Clarkes’ inquest and these changes continue to be embedded throughout the Division of Surgery and the wider Trust. Examples of the changes implemented are outlined below:

1. The discharge checklist completed by ICU/HDU staff for a patient transferred to a main ward has been updated and now includes a dual signature feature, meaning that the document must be signed by both the ICU/HDU nurse and the receiving ward nurse.
2. , Matron for ICU, has been auditing the implementation of the updated checklist since February 2025. The audit has confirmed that ICU are 84% compliant with observations completed an hour before transfer (Trust target is 80%). In respect of completion of the transfer document, the audit shows that this was completed for 82% of patients, with 96% being signed and dated by ICU and 88% signed and dated by the receiving ward.

The Division of surgery will continue to monitor this for the next six months to ensure that this improved process is fully embedded within teams.

3. In addition, as part of the joint handover, when the ICU nurse arrives with a patient who is being transferred to a ward both nurses will be in attendance for the first set of observations, which are recorded on Patientrack. Observations done at the point of transfer are being audited for our internal data capture and this remains part of the Trust’s Quality Safety Improvement Strategy and will remain an ongoing audit and key performance indicator.

4. The Division of Surgery, are focused on supporting transfers within core hours, and before 17:00 hours, to ensure that we avoid any handover period on the main wards. A daily meeting has been established (Monday to Friday) at 14:00 hours where General Surgical Elective wards including ICU, HDU and theatres, together with site coordinators and manager of the day for surgery, meet to identify appropriate patients who can be stepped down from ICU care to ward level care. The expectation is that once the patient has been identified for transfer, the main ward will actively communicate once that bed has become available. The aim to is improve communication and ensure the timely transfer of patients.

5. Whilst this new process is in its infancy, we will continue to monitor and audit this after three months in respect of improved transfer times within core hours. This will be undertaken by December 2025.

We hope that the information provided above, including the implementation of consent training and its alignment to essential training for clinical staff with patient facing roles, together with the process changes in respect of handover information and documentation and our efforts to promote safer transfer of patients, assures you and Mr Clarke’s family that we have taken the learning identified as part of our review of Mr Clarke’s care extremely seriously. We aim to use all learning positively in order to improve services and ultimately, patient care.

I would like to assure you that communication, handover, documentation and consent processes remain a focus and a priority for the organisation, and we will continue to strive for quality and the highest standards of patient care.

Please do not hesitate to contact me if you require any additional information.

Dear Mr Murray,

Thank you for the Regulation 28 report of 2 July 2025 sent to the Secretary of State for Health and Social Care about the death of Neil John Clarke. I am replying as the recently appointed new Minister with responsibility for Patient Safety.

Firstly, I would like to say how saddened I was to read of the circumstances of Mr Clarke’s death, and I offer my sincere condolences to their family and loved ones. I am grateful to you for bringing these matters to my attention. Please accept the department’s apologies for the delay in responding to this matter.

I understand NHS England have responded to you separately. I also understand, Stockport NHS Foundation Trust have also responded to you.

The first concern you raised in your report relates to considerations given to the appropriateness, from a safety and well-being perspective, of surgical procedures involving elderly patients.

You will be aware; from the response you received from NHS England that there is clear national guidance on perioperative care for both adults and specifically older people from the National Institute for Health and Care Excellence (NICE) and the British Geriatrics Society (BGS). NHS England has also undertaken considerable work to develop guidance on Early screening, triaging, risk assessment and health optimisation in perioperative pathways. This includes information on risk assessment and shared decision making. In response to your first concern, I am assured that Stockport NHS Foundation Trust have taken steps to improve information and training relating to shared decision making and consent. In July this year the Trust rolled out a mandatory training programme that all clinical staff delivering patient care are required to be enrolled on. Compliance to this training requirement is being reported through a governance process.

Your second concern relates to the accuracy of handover communications between clinical staff in respect of patients returning to the main ward from the High Dependency Unit. You will be aware that prior to the inquest into the death of Mr Clarke, that the Trust’s Divisional

Nursing Director, together with senior nursing staff have implemented and continue to embed changes to the discharge process throughout the Division of Surgery and the wider Trust. These included updating the process to the discharge checklist completed by ICU/HDU staff for a patient transferred to a main ward and a joint handover process. The Trust has audited this updated approach to ensure it is fit for purpose and will continue to monitor it.

The Government is prioritising patient safety and a learning culture in the NHS, to minimise harmful events but we also acknowledge that it is not realistic to eliminate all complications in patients undergoing life saving high risk surgery even when all reasonable mitigations are in place.

The changes being made as part of the 10-year Health Plan and report on the patient safety landscape will improve quality and thereby system safety by making it clear where responsibility and accountability sits at all levels of the system.

To drive improvements in patient safety, we will usher in a new era of transparency, a rigorous focus on high-quality care and a renewed focus on patient and staff voice.

Over recent years, the NHS has made significant strides to improve patient safety, including implementing key programmes under the NHS Patient Safety Strategy (2019). The Strategy is now achieving its aim of saving around 1000 lives per year and £100m in care costs per year.

Measures we have taken over the last year include:
• Roll out of Martha’s Rule, which is now being expanded to all acute inpatient sites. From September 2024 to July 2025 more than 260 Martha’s Rule escalation calls required transfers of care to high dependency or intensive care units, enhanced levels of care or to tertiary centres.
• implementing medical examiners on a statutory basis to scrutinise all deaths that are not investigated by a coroner, in order to facilitate learning and improvement locally.

The Care Quality Commission is also rebuilding its regulatory approach via a data-driven, intelligence-led model to enable the regulator to have a more rounded understanding of the service quality and safety Trusts are delivering.

These changes will ensure the safety and learning cultures across the NHS are more consistent.

Thank you for bringing your concerns to my attention.